Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed progesterone-receptor positive breast cancer 3 milestones | |||||
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2022-07-29 | “FDA accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine (mirvetuximab) monotherapy” abbvie.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2022-05-23 | “the US Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine monotherapy” abbvie.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2022-03-29 | “Submitted the biologics license application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine” abbvie.com ↗ “it has submitted a Biologics License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab” abbvie.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Approved | EU (EMA) | Elahere | — | 2024-11-14 | europa.eu ↗ |
| Label expansion | US (FDA) | ELAHERE | — | 2024-03-22 | fda.gov ↗ |
| Filed | US (FDA) | ELAHERE | platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer | 2023-12-05 | “FDA has filed the supplemental Biologics License Application (sBLA) supporting the conversion of the accelerated approval of ELAHERE ®” abbvie.com ↗ |
| Filed | EU (EMA) | ELAHERE | platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer | 2023-10-27 | “EMA has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE ® )” abbvie.com ↗ |
| Approved | US (FDA) | ELAHERE | — | 2022-11-14 | fda.gov ↗ |
Trials 25
News releases announcing trial results or a regulatory action · 52
| Date | Issuer | Release |
|---|---|---|
| 2026-04-12 | AbbVie | Results AbbVie Showcases Late‑Breaking Phase 2 Data for Mirvetuximab Soravtansine-gynx (ELAHERE®) in Platinum‑Sensitive Ovarian Cancer (PSOC) at SGO 2026 abbvie.com ↗
Findings highlight mirvetuximab soravtansine's potential across the ovarian cancer treatment continuum. |
| 2025-03-15 | AbbVie | Results ELAHERE® (mirvetuximab soravtansine-gynx) Shows Consistent Survival Benefit in Long-Term Analysis for Certain Ovarian Cancer Patients abbvie.com ↗
At 30.5 months median follow-up, treatment with ELAHERE continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy. |
| 2024-11-18 | AbbVie | Regulatory AbbVie Receives European Commission Approval of ELAHERE® (mirvetuximab soravtansine) for the Treatment of Platinum-Resistant Ovarian Cancer abbvie.com ↗
ELAHERE is the first and only novel therapy approved in the European Union specifically for patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer |
| 2024-09-20 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer abbvie.com ↗
The CHMP's opinion is supported by results of the Phase 3 MIRASOL clinical trial and the European Commission decision on this indication for mirvetuximab soravtansine is anticipated later this year. |
| 2024-09-09 | AbbVie | Results AbbVie Showcases Advancement of Solid Tumor Pipeline at ESMO 2024, with New Data in Tumor Types with High Unmet Needs abbvie.com ↗
The response rate seen with mirvetuximab soravtansine in PICCOLO highlights the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients. |
| 2024-06-06 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 2 PICCOLO Trial Evaluating Mirvetuximab Soravtansine (ELAHERE®) for High Folate Receptor-Alpha (FRα) Expressing Platinum-Sensitive Ovarian Cancer abbvie.com ↗
The study met its primary endpoint with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%). |
| 2024-03-22 | AbbVie | Regulatory U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients abbvie.com ↗
ELAHERE was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial. |
| 2023-12-05 | AbbVie | Regulatory FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer abbvie.com ↗
The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024 . |
| 2023-11-02 | AbbVie | Results ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results abbvie.com ↗
In addition, we advanced the ELAHERE development program and are pleased to report that our PICCOLO trial in platinum-sensitive ovarian cancer has met the primary endpoint of objective response rate based on an interim efficacy assessment. |
| 2023-10-27 | AbbVie | Regulatory ImmunoGen Announces European Medicines Agency Acceptance of Marketing Authorization Application for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer abbvie.com ↗
The acceptance of our MAA is another important regulatory milestone in the next chapter of ELAHERE’s story as we work diligently to deliver this new treatment option to patients with platinum-resistant ovarian cancer globally, |
| 2023-09-28 | AbbVie | Results ELAHERE® Shows Overall and Progression-Free Survival Benefit Regardless of Prior PARPi Exposure or Prior Lines of Therapy in FRα-Positive Platinum-Resistant Ovarian Cancer abbvie.com ↗
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced findings from two subset analyses of the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE ® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC). |
| 2023-06-04 | AbbVie | Results ELAHERE® Demonstrates 35% Reduction in the Risk of Disease Progression or Death Versus Chemotherapy in FRα-Positive Platinum-Resistant Ovarian Cancer abbvie.com ↗
Results from MIRASOL Also Show ELAHERE is the First Treatment to Demonstrate an Overall Survival Benefit in a Phase 3 Trial in Platinum-Resistant Ovarian Cancer Compared to Chemotherapy |
| 2023-05-09 | AbbVie | Results ImmunoGen Announces Results from the Phase 3 MIRASOL Trial Selected as Late-Breaking Presentation for ASCO 2023 Annual Meeting abbvie.com ↗
Having demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to investigator's choice of single-agent chemotherapy, I believe ELAHERE has the potential to be practice changing in FRα-positive, platinum-resistant ovarian cancer. |
| 2023-05-03 | AbbVie | Results ELAHERE® Demonstrates Overall Survival Benefit in the Phase 3 MIRASOL Trial in Patients with FRα-Positive Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2022-11-14 | AbbVie | Regulatory ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer abbvie.com ↗
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval for ELAHERE™ (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. |
| 2022-10-28 | AbbVie | Results ImmunoGen Presents Retrospective Analysis of Extended Treatment Benefit from Multiple Trials of Mirvetuximab Soravtansine in Ovarian Cancer at ESGO abbvie.com ↗
In a pooled analysis of 466 patients, mirvetuximab monotherapy demonstrated ETB in 40 patients (9%). |
| 2022-09-29 | AbbVie | Results ImmunoGen Presents Comprehensive Updates for Mirvetuximab Soravtansine Combination Data in Ovarian Cancer at IGCS abbvie.com ↗
Mirvetuximab Plus Bevacizumab Demonstrated Meaningful Efficacy in Recurrent FRα-Positive Ovarian Cancer Across a Broad Range of FRα Expression Regardless of Prior Treatment |
| 2022-09-11 | AbbVie | Results ImmunoGen Presents Additional Analyses Evaluating Mirvetuximab Soravtansine in Ovarian Cancer at ESMO abbvie.com ↗
today announced findings from an analysis of patient-reported outcomes (PROs) with mirvetuximab soravtansine (mirvetuximab) versus chemotherapy in the randomized Phase 3 FORWARD I study in platinum-resistant ovarian cancer. |
| 2022-07-29 | AbbVie | Regulatory ImmunoGen Reports Recent Progress and Second Quarter 2022 Financial Results abbvie.com ↗
With the BLA for MIRV accepted and receiving Priority Review designation from FDA, we have taken a significant step closer to bringing this important new therapy to ovarian cancer patients this year, |
| 2022-05-26 | AbbVie | Results ImmunoGen Presents Additional Efficacy and Safety Analyses Evaluating Mirvetuximab Soravtansine in Ovarian Cancer at ASCO abbvie.com ↗ |
| 2022-05-23 | AbbVie | Regulatory ImmunoGen Announces Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer by US Food and Drug Administration with Priority Review abbvie.com ↗
The application has been granted Priority Review designation and FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022 . |
| 2022-05-06 | AbbVie | Regulatory ImmunoGen Reports Recent Progress and First Quarter 2022 Financial Results abbvie.com ↗
Following the presentation of the results from our positive pivotal SORAYA trial at SGO, we were pleased to submit the BLA to support the accelerated approval of mirvetuximab monotherapy in FRα-high platinum-resistant ovarian cancer. |
| 2022-03-29 | AbbVie | Regulatory ImmunoGen Submits Biologics License Application to the US Food and Drug Administration for Mirvetuximab Soravtansine in Ovarian Cancer abbvie.com ↗
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that it has submitted a Biologics License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. |
| 2022-03-19 | AbbVie | Results ImmunoGen Presents Full Results from Positive Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer at SGO Annual Meeting abbvie.com ↗
With an objective response rate of 32.4%, far exceeding that seen with current therapies, and a median duration of response approaching seven months, mirvetuximab continues to demonstrate impressive efficacy in patients with platinum-resistant disease who have already received bevacizumab. |
| 2021-11-30 | AbbVie | Results ImmunoGen Announces Positive Top-Line Results from Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer abbvie.com ↗ |
| 2021-05-19 | AbbVie | Results ImmunoGen Announces Mature Data from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status abbvie.com ↗
With a 64% ORR, 11.8 month mDOR, and 10.6 month mPFS, the combination of mirvetuximab plus bevacizumab shows compelling activity in patients with high FRα recurrent ovarian cancer. |
| 2020-09-17 | AbbVie | Results ImmunoGen Presents Final Data From Phase 1b FORWARD II Triplet Cohort Evaluating Mirvetuximab Soravtansine in Combination With Carboplatin and Avastin® at ESMO abbvie.com ↗
The efficacy outcomes demonstrated by combining full dose mirvetuximab with bevacizumab and carboplatin in more heavily pretreated platinum-sensitive ovarian cancer patients is encouraging relative to current standard of care triplet regimens. |
| 2020-05-29 | AbbVie | Results ImmunoGen Presents Initial Data at ASCO from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status abbvie.com ↗
We are particularly encouraged by the overall response rate of 64% observed in patients with high FRα expression, regardless of platinum status. |
| 2020-05-13 | AbbVie | Results ImmunoGen Announces Initial Data from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status abbvie.com ↗
today announced initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin ® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. |
| 2019-12-17 | AbbVie | Regulatory ImmunoGen Announces Accelerated Approval Pathway for Mirvetuximab Soravtansine in Ovarian Cancer abbvie.com ↗
the U.S. Food and Drug Administration ( FDA ) has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. |
| 2019-09-29 | AbbVie | Results ImmunoGen Presents Initial Data from Phase 1b FORWARD II Triplet Cohort Evaluating Mirvetuximab Soravtansine in Combination with Carboplatin and Avastin® at ESMO abbvie.com ↗ |
| 2019-05-15 | AbbVie | Regulatory ImmunoGen Provides Regulatory Update on Mirvetuximab Soravtansine Monotherapy in Ovarian Cancer abbvie.com ↗
The agency advised that, because FORWARD I did not meet its primary endpoint under the pre-specified statistical analysis plan, the data generated assessing the secondary endpoints from the study could not be used to support an application for accelerated approval. |
| 2019-05-15 | AbbVie | Results ImmunoGen Announces Mature Data from FORWARD II Expansion Cohort Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Ovarian Cancer abbvie.com ↗ |
| 2019-05-03 | AbbVie | Results ImmunoGen Reports Recent Progress and First Quarter 2019 Financial Results abbvie.com ↗ |
| 2019-03-01 | AbbVie | Results ImmunoGen Announces Top-Line Results from Phase 3 FORWARD I Study of Mirvetuximab Soravtansine in Ovarian Cancer abbvie.com ↗
Trial Did Not Meet Primary Endpoint of Progression-Free Survival |
| 2018-10-20 | AbbVie | Results ImmunoGen Presents Initial Data from FORWARD II Expansion Cohort Assessing Mirvetuximab Soravtansine in Combination with KEYTRUDA at ESMO 2018 Congress abbvie.com ↗
Preliminary Data Demonstrate Favorable Safety Profile and Encouraging Activity in Heavily Pretreated Patients with Ovarian Cancer |
| 2018-06-18 | AbbVie | Regulatory ImmunoGen Announces FDA Fast Track Designation for Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer abbvie.com ↗
“We are pleased the FDA has granted Fast Track designation for mirvetuximab soravtansine,” said Mark Enyedy , ImmunoGen’s President and Chief Executive Officer. |
| 2018-05-16 | AbbVie | Results ImmunoGen Announces Positive Findings from the FORWARD II Study of Mirvetuximab Soravtansine Combination Regimens with Avastin® and Carboplatin in Ovarian Cancer abbvie.com ↗ |
| 2018-04-26 | AbbVie | Results ImmunoGen Announces Successful Completion of Interim Analysis for FORWARD I Phase 3 Trial of Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer abbvie.com ↗
The decision follows a recommendation by the Independent Data Monitoring Committee (IDMC) based upon successful completion of a pre-specified interim futility analysis after 80 progression-free survival (PFS) events as determined by blinded, independent central review. |
| 2018-03-24 | AbbVie | Results ImmunoGen Presents Data from FORWARD II Assessment of Mirvetuximab Soravtansine in Combination with Pembrolizumab at the Society of Gynecologic Oncology Annual Meeting abbvie.com ↗
today announced encouraging efficacy and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy pembrolizumab in patients with platinum-resistant epithelial ovarian cancer (EOC). |
| 2017-05-17 | AbbVie | Results ImmunoGen Announces New Clinical Data with Mirvetuximab Soravtansine in Ovarian Cancer to be Presented at 2017 ASCO Annual Meeting abbvie.com ↗
Pooled analyses of Phase 1 expansion cohorts demonstrate clinically meaningful activity in patient population being studied in FORWARD I registration trial |
| 2017-05-01 | AbbVie | Results ImmunoGen Announces Results from Mirvetuximab Soravtansine Phase 1 First-in-Human Dose-Escalation Trial Published in Cancer abbvie.com ↗ |
| 2017-03-12 | AbbVie | Results ImmunoGen Presents Phase 1 Biopsy Expansion Cohort Data at the Society of Gynecologic Oncology Annual Meeting abbvie.com ↗
More broadly, the data being presented confirm that in this heavily pretreated cohort, mirvetuximab soravtansine is well tolerated and that the higher the FRα expression, the greater the anti-tumor activity. |
| 2016-12-28 | AbbVie | Results ImmunoGen Announces Mirvetuximab Soravtansine Phase 1 Expansion Cohort Results in Platinum-Resistant Ovarian Cancer Published in the Journal of Clinical Oncology abbvie.com ↗
Mirvetuximab soravtansine demonstrated single-agent activity in the 46-patient cohort with a 26% confirmed response rate and median progression free survival (PFS) of 4.8 months. |
| 2016-11-11 | AbbVie | Results ImmunoGen to Present Preclinical Data Highlighting Potential of Combining Mirvetuximab Soravtansine with an Immune Checkpoint Inhibitor at SITC 2016 Annual Meeting abbvie.com ↗
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced new preclinical data that demonstrate the potential for enhanced activity when combining mirvetuximab soravtansine with immune checkpoint inhibition. |
| 2016-05-18 | AbbVie | Results ImmunoGen Reports Efficacy and Safety Data from a 46-Patient Cohort of Mirvetuximab Soravtansine in FRα-Positive Ovarian Cancer abbvie.com ↗
Among all 46 patients, the confirmed objective response rate (ORR) was 26% and median progression-free survival (PFS) was 4.8 months (95% confidence interval, 3.9-5.7 months). |
| 2015-11-08 | AbbVie | Results Treatment Response to ImmunoGen's Mirvetuximab Soravtansine Found to be Substantially Greater in Ovarian Cancer with High Expression of Folate Receptor Alpha abbvie.com ↗ |
| 2015-05-30 | AbbVie | Results ImmunoGen's Mirvetuximab Soravtansine (IMGN853) Demonstrates Notable Single Agent Activity for Patients with Platinum-Resistant Ovarian Cancer abbvie.com ↗
Objective response rate (ORR) of 53% - as single agent - in patients with folate-receptor alpha (FRα)-positive platinum-resistant ovarian cancer. |
| 2014-05-14 | AbbVie | Results ImmunoGen, Inc. Announces Clinical Data Presentations at Upcoming 50th Annual Meeting of ASCO abbvie.com ↗
Abstracts made public today provide insight on biological effects seen at low doses with IMGN529 and on observed activity threshold for IMGN853. |
| 2013-06-03 | AbbVie | Results First Clinical Data Presented with IMGN853, ImmunoGen, Inc.'s Potential New Therapy for Ovarian and Other Cancers abbvie.com ↗
DLT, seen at 7.0 mg/kg, was reversible blurred vision with epithelial corneal changes. |
| 2012-04-17 | AbbVie | Regulatory ImmunoGen, Inc. Announces the IND Is Now Active for Its Folate-Receptor Targeting Anticancer Compound, IMGN853 abbvie.com ↗
ImmunoGen, Inc . (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics, today announced that the Investigational New Drug (IND) application for its IMGN853 product candidate is now active. |
| 2011-04-04 | AbbVie | Results ImmunoGen, Inc. Announces First Data for its Novel Therapeutic for Ovarian Cancer and Other Carcinomas abbvie.com ↗
IMGN853 was found to be highly effective against human ovarian cancer tumors in preclinical testing. |
All press releases naming this drug 61 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mirvetuximab Soravtansine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03106077 ↗ |
| Known as | IMGN853 | “A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With...” NCT02631876 ↗6“Carboplatin (AUC5, d1) + Mirvetuximab soravtansine (IMGN853) 6 mg/kg IV d1 x 6 cycles q21d, followed by subsequent monotherapy of Mirvetuximab soravtansine (IMGN853) 6 mg/kg IV...” NCT04274426 ↗ “Phase I Study of Mirvetuximab Soravtansine (IMGN853) and Rucaparib for Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer” NCT03552471 ↗ “Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC)” NCT04606914 ↗ “Mirvetuximab Soravtansine (IMGN853)” NCT03045393 ↗ |
| Known as | MIRV | “OBJECTIVE: Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients...” PMID 40700855 ↗ Jul 20256“Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate (ADC) consisting of the humanized anti-FRα monoclonal antibody M9346A covalently linked to the cytotoxic...” NCT07825753 ↗ “Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent...” PMID 33667670 ↗ Mar 2021 “Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC)” NCT04606914 ↗ “Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC.” NCT07059845 ↗ “Mirvetuximab Soravtansine (MIRV)” NCT07218809 ↗ |
| Known as | mirvetuximab | “Mirvetuximab soravtansine is a monoclonal antibody, called mirvetuximab, linked to a chemotherapy drug called DM4.” NCT02996825 ↗ |
| Known as | mirvetuximab soravtansine-gynx | “BACKGROUND: Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class, folate receptor alpha (FRα)-targeting antibody-drug conjugate with United States Food and Drug...” PMID 39617145 ↗ Nov 20243“OBJECTIVE: Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients...” PMID 40700855 ↗ Jul 2025 “Mirvetuximab soravtansine-gynx (MIRV), an antibody-drug conjugate, comprises a folate receptor alpha (FRα)-binding antibody and tubulin-targeting payload (maytansinoid DM4).” PMID 39082675 ↗ Jul 2024 |
| Action | Deplete | “may help find certain tumor cells and kill them without harming normal cells.” NCT03552471 ↗ |
| Modality | Other / unclassified | “Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in patients with...” PMID 40700855 ↗ Jul 2025 |
| Route | Intravenous | “Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.” NCT01609556 ↗ |
| Target | FOLR1 | “Mirvetuximab attaches to FOLR1 positive cancer cells in a targeted way” NCT02996825 ↗ |